UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028731
Receipt number R000031553
Scientific Title Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy
Date of disclosure of the study information 2017/08/18
Last modified on 2019/02/18 11:03:01

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Basic information

Public title

Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy

Acronym

Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy

Scientific Title

Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy

Scientific Title:Acronym

Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The efficacy of pulse wave transit time in patients undergoing robot-assisted radical prostatectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The aim of this study is to evaluate the ability of PWTT compared with cardiac output measured by APCO in patients undergoing robot-assisted radical prostatectomy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

The patients that robot-assisted radical prostatectomy was planned under general anesthesia.

Key exclusion criteria

Atrial fibrillation
Moderate or severe aortic stenosis
Moderate or severe aortic regurgitation
The arterial catheterisation is the patient of contraindication.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Sguiura

Organization

National hospital organization Tokyo medical center

Division name

Anesthesiology

Zip code


Address

2-5-1, Higashigaoka, Meguro-ku, Tokyo

TEL

03-3411-0111

Email

sugiura.takahiro@navy.plala.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Sugiura

Organization

National hospital organization Tokyo medical center

Division name

Anesthesiology

Zip code


Address

2-5-1, Higashigaoka, Meguro-ku, Tokyo

TEL

03-3411-0111

Homepage URL


Email

sugiura.takahiro@navy.plala.or.jp


Sponsor or person

Institute

Ntional hospital organization Tokyo medical center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2017 Year 07 Month 07 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

From records such as an electrocardiogram, the oxygen saturation in the practice, we evaluate pulse wave transmission time retrospectively.


Management information

Registered date

2017 Year 08 Month 18 Day

Last modified on

2019 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031553